Incidence Assessment of Gingival Fissures Associated with the Use of Manual and Electric Toothbrushes: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Gingival fissures
研究概览
简要总结
Gingival fissures (GF) have been suggested as risk indicators for clinical attachment loss (CAL) and gingival recession, especially in free surfaces and in patients with low plaque scores. The major factors related to the GF occurrence are high daily brushing frequencies, excessive force to brush, malpositioned teeth, use of abrasive dentifrices, and stiffness of the toothbrushes bristles. Thus, in order to better understand the pathogenesis and progression of GF, this study aim to evaluate the incidence of GF in young adults using manual and electric soft toothbrushes, in a cross-over randomized clinical trial along 2 months.
详细描述
Sample:
- Sample Calculation: The sample size calculation was based on the study by Greggianin et al., (2013) considering the smallest differences between means present. The result determined 28 participants in a crossover study, with a significance level of 0.05; study power of 0.8 according to calculations performed on the website: http://hedwig.mgh.harvard.edu/sample_size/js/js_crossover_quant.html. Considering an attrition rate of 20%, the number of participants included should be 34.
- Recruitment: Students duly enrolled in high school classes at Colégio Tiradentes, Porto Alegre/RS, will be invited to participate in this study. The sample will be recruited from the verbal invitation by the researchers in the classroom. The invitation will contain the study objectives, volunteer profile, inclusion and exclusion criteria, a summary of the research procedures, as well as the risks and benefits that the study will bring to the participants, and contact information for the researchers. At the end of this invitation, the students will receive the informed consent form for participants over the age of 18 or the parent/guardian informed consent form + ICF. These terms must be returned signed within one week in case of interest in participating in the study. The following week, those interested in participating who return the terms will undergo a dental examination to confirm their inclusion in the study. If eligible, they will be scheduled to begin the study.
Oral hygiene tools:
- Hand brushes: toothbrushes with soft texture, multi-strand, small head and flat surface will be purchased, by the researchers, in the local market from the same manufacturer, type and lot.
- Electric toothbrushes: electric toothbrushes will be obtained in the local market from the same manufacturer, type and lot. In this study, soft tips will be used, with a small oval head, multiple bristle, flat and soft. The electric toothbrushes have a straight, flat handle, and are waterproof.
- Toothpaste: fluoride toothpastes, with no therapeutic action, of low abrasion (containing silica) will be distributed to the participants according to their consumption. The dentifrices, belonging to the same lot, will be purchased by the researchers in the local market.
Assessment procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good systemic health (ASA I and II); No history of periodontitis (no interproximal bone loss ≥ 3 mm); No gingival recession ≥ 3 mm; Minimum number of 20 teeth.
排除标准
- •Use of medications that alter in some way the gingival and/or periodontal inflammatory response (phenytoin, sodium valproate, nifedipine, verapramil, diltiazem amlodipine, felodipine, cyclosporine [Murakami et al., 2018]); Having had antibiotic therapy in the last three months; Crowding; Presence of restorations and/or carious lesions in the cervical region on the buccal surfaces; Being under orthodontic treatment; Type 1 or 2 Diabetes Mellitus; Being a smoker; Being pregnant; Presence of full crowns and/or implants; Need for antibiotic prophylaxis for periodontal examination;
结局指标
主要结局
Gingival fissures
时间窗: From enrollment to the end of experimental time (2 months)
Clinical examination, under disclosing solution, will evaluate the presence of gingival fissures (GF) on the buccal surfaces of all teeth, except third molars. Additionally, the measurement of the GF will be performed with the aid of a North Carolina periodontal probe, positioned following the path of the GF from the gingival margin to the most apical portion of the lesion.
次要结局
- Toothbrush wear(From enrollment to the end of experimental time (2 months))
研究者
Rui Vicente Oppermann
PhD
Federal University of Rio Grande do Sul